On June 2, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that it has expanded its existing collaboration with Advanced BioMatrix, a division of BICO Group AB (STO: BICO), for Lineage’s HyStem cell/drug delivery technology (Press release, Lineage Cell Therapeutics, JUN 2, 2022, View Source [SID1234615499]). Under the expanded collaboration, Advanced BioMatrix will broaden its current focus of manufacturing and supplying R&D-grade HyStem to the research community to include the development, supply and/or licensing of clinical/commercial GMP- (Good Manufacturing Practice) grade material for its customers. The amended agreement increases the milestone payments and royalty percentages due to Lineage upon ABM reaching certain development milestones and/or product sales.

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"We are pleased to broaden the scope of our agreement with Advanced BioMatrix and the opportunity to include the commercial supply of clinical-grade HyStem as part of ABM’s biomaterials & bioprinting portfolio which is widely available to the cell therapy product development community," stated Brian M. Culley, Lineage CEO. "We have decided this year to place a greater emphasis on business development and licensing and we believe the decision to broaden our partnership with ABM is an example of our ability to rapidly monetize prior investments in our technology platform and its related intellectual property. Alongside our prioritized assets, other assets which are not core to our cell transplant platform can create new opportunities for cash flow and support our development pipeline. Our strategy is to identify and pursue opportunities to unlock value from our business and to utilize capital from these corporate alliances to advance our novel cell therapy programs."

"The mission of Advanced BioMatrix is to enable the future of life-saving treatments, and the HyStem technology can now be more fully utilized as a tool towards accomplishing this mission," added Bowman Bagley, Advanced BioMatrix CEO.

HyStem is a patented hydrogel which mimics naturally occurring extracellular matrix, the structural network of molecules surrounding cells in organs and tissues and essential to cellular function and tissue structure. HyStem biomaterial has been shown to support cellular attachment and survival as well as compatibility with a wide variety of cells and tissue types including brain, bone, skin, cartilage, vascular and heart tissues.

On June 2, 2022 Mereo BioPharma Group plc (NASDAQ: MREO), ("Mereo" or "the Company"), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, reported updated clinical data from its open-label Phase 1b/2 Study of Etigilimab and Nivolumab in subjects with Select Locally Advanced or Metastatic Solid Tumors (ACTIVATE) (Press release, Mereo BioPharma, JUN 2, 2022, View Source [SID1234615414]). The data will be presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5, 2022. The Company also provided an update on its capital allocation and portfolio prioritization plan.

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The multicenter ACTIVATE study is designed to evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics of etigilimab, in combination with nivolumab, with dosing every two weeks.

As of the cut off date of April 20, 2022, there were 38 efficacy-evaluable subjects with a minimum of 1 staging scan or documented clinical progression. Treatment of etigilimab in combination with nivolumab has shown preliminary efficacy across multiple tumor types with 2 complete responses (CRs), 4 partial responses (PRs), and 10 stable disease (SDs) for an overall response rate (ORR) of 15.8% and disease control rate (DCR) of 42.1% in heavily pre-treated, CPI-naïve subjects. Additionally, 7 subjects with clinical benefit remained on study treatment for ≥ 18 weeks. Clinical benefit was noted in tumor types not typically responsive to immune checkpoint inhibitor monotherapy. The combination of etigilimab and nivolumab has been safe and well tolerated, with no new treatment-related SAEs or safety signals observed to-date.

"We are very pleased with these updated results from the ACTIVATE study and look forward to sharing our findings at ASCO (Free ASCO Whitepaper)," said Dr. Suba Krishnan, Senior Vice President, Clinical Development of Mereo. "We are encouraged by the results reported as of the cut-off date, especially the early efficacy noted in cervical cancer, where we have seen two complete responses and two cases of stable disease among five subjects, and in uveal melanoma subjects in the rare tumor cohort, where we saw one partial response and two stable disease with over 20 weeks on study treatment. While these early data are encouraging for our differentiated clinical strategy, we will continue to monitor emerging clinical data on other anti-TIGIT therapeutics as we determine the most appropriate path forward for etigilimab."

Updated Capital Allocation and Portfolio Prioritization Plan
Mereo also announced the outcome of a review to update its capital allocation strategy, including general and administrative and other costs, and portfolio prioritization in light of current market conditions and recent industry clinical data announcements. This review was undertaken with the aim of maximizing shareholder value. Based on these initiatives, the Company now expects its current cash runway will be extended from "into" 2024 to late 2024.

The portfolio, in order of development stage, is as follows:

Setrusumab for Osteogenesis Imperfecta (OI): As planned, Mereo will target its investment toward the activities required in support of the EU and UK territories and the ongoing collaboration with Ultragenyx Pharmaceutical, Inc. The Phase 2/3 in 5-25 year olds has been initiated by Ultragenyx and an update on the Phase 2 is expected before the end of 2022.
Alvelestat for Alpha-1-Anti-Trypsin Deficiency (AATD): Mereo recently announced positive top-line data from the Phase 2 study of alvelestat in AATD. The Company intends to complete further analysis of the Phase 2 data during 2H 2022 and will evaluate further options for the program once it has completed an end-of-Phase 2 meeting with the FDA (intended by end of 2022) and an EMA scientific advisory meeting (thereafter). As previously planned, no additional clinical development expense will be incurred for this program from the current cash resources.
Etigilimab in Oncology: Mereo intends to complete enrollment in the Phase 1b part of the previously planned Phase 1b/2 study in Q3 2022. The Company will then evaluate further options based on the Phase 1b data and external factors, including clinical data from other anti-TIGIT programs.
Mereo will continue to explore a range of additional financing options for its programs, including partnerships, which may include retention of certain rights and/or territories, as well as non-dilutive financing.

"We conducted this strategic review over the last few months in light of current market conditions and emerging external clinical data, to focus the Company’s resources on our lead programs," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "As a result of our updated capital allocation plan, our current cash balance of $111.4 million (as of March 31, 2022) will now support our operating runway into late 2024. We believe this puts Mereo in a stronger position to maximize shareholder value and deliver on multiple milestones over the next two years as we focus on our mission of developing transformative therapies."

Details of the ASCO (Free ASCO Whitepaper) data presentation are as follows:
Abstract Title: A Phase 1b/2 Study of Etigilimab (MPH313) and Nivolumab in Subjects with Select Locally Advanced or Metastatic Solid Tumors (ACTIVATE)
Session Date & Time: Sunday, June 5 at 9AM ET
Session Title: Developmental Therapeutics—Immunotherapy
Abstract ID: 2651

On June 2, 2022 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that management will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Monday, June 13 at 4:20 p.m. ET / 1:20 p.m. PT in Rancho Palos Verdes, Calif (Press release, Arvinas, JUN 2, 2022, View Source [SID1234615430]).

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A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company’s website.

On June 2, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported interim clinical data, including a confirmed PR per mRANO (meaning >50% reduction in tumor measurements) in a glioblastoma (GBM) patient from its ongoing Phase 1-2 study in patients with advanced unresectable and metastatic solid tumors (NCT04478279) (Press release, Sapience Therapeutics, JUN 2, 2022, View Source [SID1234615448]).

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In the Phase 2 expansion portion of the ongoing Phase 1-2 study of ST101, 14 GBM patients have been enrolled to date. Of these 14 patients, one patient has a confirmed PR after 18 weeks of therapy, seven patients have not reached the first on-study assessment, and six patients progressed. In both the Phase 1 and Phase 2 portions of the ongoing study, ST101 has demonstrated a favorable safety profile, with manageable mild-moderate infusion related reactions as the most common adverse event. Based on the confirmed PR announced today, Sapience intends to expand the recurrent GBM cohort to enroll additional patients.

"ST101 is showing promising results in GBM with a PR, which we have confirmed with repeat scans per mRANO and using an independent radiology reviewer. The tumor shrinkage we are seeing is especially encouraging given the significant unmet medical need in this disease and its poor prognosis," said Fabio Iwamoto, Principal Investigator at Columbia University. "Our team at Columbia is thrilled to be a part of this work and to deliver meaningful therapeutic benefit to cancer patients."

Dr. Alice Bexon, Sapience’s Chief Medical Officer, added, "The confirmed response in GBM is very exciting news, which along with the continuing clinical benefit we are seeing from some of the Phase 1 patients, suggests that ST101 could make a major contribution to the treatment of cancer. Based on its novel mechanism of action, ST101 is the first in a new class of peptide therapeutics, and we look forward to advancing our Phase 2 study."

Data from the ST101 Phase 1 study will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on Sunday, June 5th, 2022, Abstract #3014.

About ST101 and the Phase 1-2 Study

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). ST101-101 is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: Phase 1 dose escalation/regimen exploration and Phase 2 expansion. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a durable RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, ST101 has demonstrated clinical proof-of-concept with a confirmed partial response in a patient with recurrent GBM. Sapience is actively enrolling patients with GBM, metastatic cutaneous melanoma, locally advanced or metastatic hormone-receptor positive breast cancer and castration-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as orphan designations from the FDA for advanced melanoma, glioma and AML, and from the European Commission for the treatment of glioma.

On June 2, 2022 National Resilience, Inc. (Resilience) and The University of Texas MD Anderson Cancer Center reported the launch of a joint venture, the Cell Therapy Manufacturing Center, to accelerate the development and manufacturing of innovative cell therapies for patients with cancer (Press release, National Resilience, JUN 2, 2022, View Source [SID1234615464]). Uniting the strengths of Resilience and MD Anderson, the joint venture will advance its work within a culture of academic innovation alongside industrial expertise.

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The Cell Therapy Manufacturing Center will be based in a state-of-the art 60,000-square-foot manufacturing facility in the Texas Medical Center, with a team of 70 employees focused on process and analytical development as well as early-phase and clinical-stage Good Manufacturing Practices (GMP).

The joint venture combines MD Anderson’s expertise in immunotherapy and cell therapies as well as a leading clinical trials infrastructure, with Resilience’s innovative biomanufacturing technologies, advanced analytics and a national network for developing and producing cell therapies. Together, the parties aim to accelerate the path of cell therapies to the clinic, while enabling scalability and a smooth transition to late-phase clinical and commercial activities.

"Cell therapies have had a dramatic impact for patients with certain cancers, but progress has been hampered by structural challenges," said Jason Bock, Ph.D., Chief Executive Officer of the Cell Therapy Manufacturing Center. "This novel joint venture was conceived to address those challenges by harnessing the complementary capabilities of two world-class organizations, allowing us to advance innovative programs to deliver impactful therapies to patients."

The joint venture will engage with MD Anderson researchers and external industry collaborators to advance new therapies through preclinical and clinical development, ensuring consistent and safe products that can be evaluated rapidly in clinical trials led by MD Anderson physicians. Resilience customers will be able to leverage this offering as part of the company’s growing network of biomanufacturing facilities that are flexible enough to scale projects from small-batch pre-clinical to large-scale commercial production. Resilience has 10 facilities across North America, with more than 1 million square feet of manufacturing space.

"The promise of cell therapies to help patients in need has been limited by a lack of innovation in biomanufacturing," said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. "This collaboration aims to overcome those hurdles by extending our network with this unique partnership, creating opportunities to incubate innovative ideas and provide cutting-edge biomanufacturing technologies and processes to researchers, with a goal of bringing more cell therapies to patients."

The joint venture will advance the most promising cell therapy modalities to answer unmet clinical needs, including engineered tumor infiltrating lymphocytes (TILs), chimeric antigen receptor (CAR)-modified T cells, endogenous T cells (ETCs), engineered natural killer (NK) cells and other emerging technologies, for patients with hematological and solid tumors. MD Anderson researchers are leaders in the field of cancer cell therapy, responsible for advancing the translational and clinical development of many of the currently approved and experimental cell therapies.

The joint venture is built upon MD Anderson’s Biologics Development platform, formerly part of the institution’s Therapeutics Discovery division. Current strategic collaborations with MD Anderson’s Biologics Development platform will continue; collaborative relationships with MD Anderson’s Therapeutics Discovery division, as well as physicians and scientists across the institution, also will be maintained.

"We believe in the tremendous potential of cell therapies to deliver solutions that offer cures, not merely prolonged survival. Resilience offers unique capabilities that make it an ideal choice for unlocking that potential and accelerating impactful cell therapies," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Relations at MD Anderson. "Our mission at MD Anderson is to end cancer, and this joint venture is a strategic step toward realizing that goal."